Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
CardioChek Plus Test System, CardioChek Home Test System
SKU K162282UPC CGA
In Stock
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IIFDA 510(k) Cleared (K162282)
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Free shipping on orders over $99 · 30-day returns
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
Free shipping on orders over $99 · 30-day returns
CardioChek Plus Test System, CardioChek Home Test System is an FDA 510(k)-cleared medical device (K162282) manufactured by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2016. Regulation: 8.
